Z-2707-2024 Class II Ongoing
FDA device recall Z-2707-2024 was initiated by MEDLINE INDUSTRIES, LP - Northfield on Mar 22, 2024 and is designated Class II. Reason for recall: A slight dimensional variation which has the potential for increased difficulty fitting into outer canister. The recall status is ongoing. Affected quantity: 3539 units.
Recall Details
- Product Type
- Devices
- Report Date
- Aug 28, 2024
- Initiation Date
- Mar 22, 2024
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 3539 units
Product Description
Medline medical procedure kits labeled as follows: a) MAJOR BREAST, REF DYNJ905004C; b) MINOR BREAST, REF DYNJ905002B; c) SUCTION MEDI VAC, REF DYKM2033
Reason for Recall
A slight dimensional variation which has the potential for increased difficulty fitting into outer canister.
Distribution Pattern
Worldwide - US Nationwide and the countries of Panama, Mexico, Canada, Qatar, El Salvador, Oman, Colombia, Singapore.
Code Information
a) REF DYNJ905004C, UDI/DI 40195327316939 (case), 10195327316938 (unit), Lot Numbers: 23CBG213, 23EBI690, 23FBT057, 23GBB635, 23IBA478, 23JBB064; b) REF DYNJ905002B, UDI/DI 40195327316861 (case), 10195327316860 (unit), Lot Numbers: 23ABK521, 23BBG561, 23CBU161, 23EBE334; c) REF DYKM2033, UDI/DI 40193489849241 (case), 10193489849240 (unit), Lot Numbers: 22FMF595, 22HMB247, 22HMD137, 22LMD691, 22LMH566, 23BMG473, 23DMI525, 23FMG464, 23GMH062, 23IMH701, 23KMA183
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-2707-2024
- openFDA file date
- Oct 23, 2026
- Loaded by RegDataLab
- Oct 25, 2026